MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. ATLAS; ATLAS TRANSFER CARRIAGE

Model Number	AX0660230830000013
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the transfer carriage, loading cart and sterilizer.The technician found no issues with the function or operation of the loading cart, transfer carriage, or sterilizer.While onsite the technician spoke with user facility personnel and learned that when the transfer carriage was being engaged with the sterilizer, the transfer carriage "sprung" back contacting the employee's hand resulting in the reported event.The cause of the reported event is likely attributed to user error.The atlas transfer carriage operator manual (pg.3-2) states, "align loading car and atlas¿ transfer carriage with rails inside sterilizer chamber and push transfer carriage forward until front latches (fig.3-1) are engaged in end-frame slots (fig.3-2)." in-service training is pending on the proper use and operation of the atlas transfer carriage.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that an employee obtained a small cut on their hand while operating their atlas transfer carriage.The employee self-treated by applying a bandage.
Additional Manufacturer Narrative
Steris offered in-service training on the proper use and operation of the atlas transfer carriage; however, the user facility declined.No additional issues have been reported.

• Brand Name: ATLAS
• Common Device Name: ATLAS TRANSFER CARRIAGE
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 22154258
• Report Number: 3005899764-2025-00046
• Device Sequence Number: 12717244
• Product Code: FLE
• UDI-Device Identifier: 00724995150631
• UDI-Public: (01)00724995150631(11)170801
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AX0660230830000013
• Device Catalogue Number: AX0660230830000013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown